Section: V1M2, Section 4.13.3
Throughout the 2016 TNI Standard, and specifically within section V1M2: 4.13.3, the laboratory is required to produce, ensure, implement, etc., a system that produces records that document all laboratory activities, have documentation that allows historical reconstruction, etc. Labs are also required to have and maintain SOPs that meet all of the method and regulatory requirements as well as accurately reflect the laboratory’s operations, and the analysts are required to read, understand, and follow their SOPs.
Question: Is the laboratory required to have a record, that they fill out like a benchsheet or logbook (or whatever terminology the lab might use), electronic or hardcopy, where they document every step of the test or every action that is taken in the laboratory? Such as:
- exact times of each step of a organics sample extraction
- reaction times/wait times of a sample digestion or extraction
- pH checks within a sample digestion/extraction (note, not a pH check for preservation acceptance purposes, but a pH adjustment that is required within a digestion/extraction step)
Or, is having these times, steps, requirements, etc. listed in the SOP acceptable as part of the laboratory's proof of 'historical reconstruction' of all laboratory activities?
TNI FINAL RESPONSE:
No, the laboratory is not required to have a record that they fill out like a bench sheet or logbook (or whatever terminology the lab might use), electronic or hardcopy, where they document every step of the test or every action that is taken in the laboratory. However, a record keeping system that allows the history of the sample and associated data to be readily understood through documentation and that documents all laboratory activities is required per TNI V1M2 4.13.3.a). While an SOP is part of the historical reconstruction of the sample and associated data, per TNI V1M2 4.13.3 f) ii, "...reference to the specific method used..." is part of the "information necessary for the historical reconstruction of data", it would not produce a complete record of the history of the sample.
Per TNI V1M2 4.13.3 f) v, "time of analysis is required if the holding time is seventy-two (72) hours or less, or when time critical steps are included in the analysis (e.g., extractions and incubations)" and per TNI V1M2 126.96.36.199 "observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task." Therefore, a record is required for these instances.